Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris

Part of paid clinical trials in Miami, Florida.

Sponsor
Kane Biotech Inc
Study ID
NCT06729450
Status
Not Yet Recruiting

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Conditions

  • Acne Vulgaris on the Face

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DispersinB Acne Cleanser — DEVICE
    DispersinB Acne Cleanser, strength: 80 ug/g, topical gel

Study Details

This is a single-center study using intra-individual comparison (right half-face versus left half-face) to evaluate the efficacy and tolerability of DispersinB Acne Cleanser for treatment of acne in adults. An initial sample size of 24 subjects is planned to be randomized in order to provide proof of concept efficacy and tolerability of the product. The main questions it aims to answer are: 1. Percent of subjects rated "Clear" and "Almost Clear" on a 5-point scale 0=clear; 4=severe) at 12 weeks 2. Change in inflammatory and noninflammatory lesion count per half-face at 12 weeks Researchers will compare each half-face: * one half facial wash with DispersinB Acne Cleanser and 4% Benzoyl Peroxide. * one half facial wash with 4% Benzoyl Peroxide only Subjects will use the DispersinB Acne Cleanser on the assigned facial side for 5 minutes and then will use the provided 4% Benzoyl peroxide facial wash to wash entire face for daily (evening) use.

Key Dates

Start date
Jan 30, 2026
Status verified
May 2025
Primary completion
Oct 31, 2026
Completion
Dec 16, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: intra-individual Split-face comparison
    Subjects will complete baseline assessments and be randomized (left face versus right face) to apply DispersinB Acne Cleanser over at 12-week treatment period, for an intra-individual, split-face comparison. Subjects will use the DispersinB Acne Cleanser on the assigned facial side for 5 minutes and then will use the provided 4% Benzoyl peroxide facial wash to wash entire face for daily (evening) use.

Primary Outcome Measure

Success rate per half-face [ Time Frame: Baseline to week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33124
Kane Prinicipal Investigator
1305-243-1000

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